Pre-sterilizable carrier systems and methods for the filling thereof are known. A known carrier system comprises usually washed, siliconized and sterilized syringes, which are placed in a magazine after the washing and siliconizing step. The magazine—also referred to as a nest—is subsequently placed in a container which is then sealed with a closure element, preferably a gas-permeable membrane film, and sterilized via suitable sterilization methods. An ethylene oxide gassing is often used hereby. Because the closure element is gas-permeable, the sterilization gas can penetrate into the interior of the container and also sterilize the contents of the container, that is, the washed and siliconized syringes as well as the magazine holding them. The container does not need to be opened again after the sterilization step and can be delivered in the present form directly to a customer or to a filling line. The gas-permeable closure element namely has a filter effect such that although it is permeable for a sterilization gas, it closes the container in a tight and sterile manner with respect to germs, viruses and bacteria. As long as the container remains closed, the sterility of the contents thereof is therefore ensured. With a customer who typically operates a filling machine for filling the syringes or other hollow bodies with pharmaceutical contents held by the container, the container is opened, the hollow bodies are filled and closed, whereupon the container can be again closed and transported to the end customer. Of course, the filled and closed hollow bodies can also be removed from the container and passed to the end customer in different packaging units. The essential factor in the cited pre-sterilized carrier systems and the method for the filling thereof is that a standardized packaging form is used which can be used in connection with standardized filling lines. The hollow bodies to be filled therefore do not need to be removed from the container before filling, whereby a complex process step is omitted. Furthermore, it is advantageous that the hollow bodies can be sterilized jointly in an already packaged form, after which shipping or further processing can take place without complex interim steps such as a new packaging in a pre-sterilized further packaging unit or repackaging being necessary. In a manufacturing pharmaceutical company that carries out the filling, a clean room or process step for preparing the hollow bodies can be omitted, since they are supplied ready for filling.
The production and/or preparation of the hollow bodies can also be carried out as an in-line process with the filling, if a hot-air tunnel is provided between the sterilization device and the clean room in which the filling takes place.
The known pre-sterilizable carrier systems and the methods for the filling thereof, however, are designed only for single-chamber systems, that is, single-chamber syringes, single-chamber carpules or vials. In order to fill dual-chamber systems such as dual-chamber syringes or carpules, more complex methods and carrier devices are therefore still necessary.
If dual-chamber systems are used in conventional filling methods in connection with a freeze drying step for a solution located in one of the two chambers, special closure elements—so-called Lyo closures—are used. A closure element of this type is thereby assigned to each individual dual-chamber system. These Lyo closures have two click-stop positions on the dual-chamber system: in a first click-stop position they seal the dual-chamber system in a manner such that a gas exchange between the interior of the chamber closed with the closure element and the environment can take place. In a second click-stop position the closure element closes the chamber completely. In conventional processes the dual-chamber systems are sorted in heavy, reusable metal magazines. These have the disadvantage of being difficult to handle due to their great weight. Furthermore, they have to be laboriously cleaned and sterilized, typically autoclaved, before each use.